Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-03 @ 6:41 AM
Study NCT ID:
NCT03898167
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Evaluation of Self-Testing to Increase Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jrmontealegre@mdanderson.org', 'phone': '713-792-0919', 'title': 'Dr. Jane Montealegre', 'organization': 'The University of Texas MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants knew self-collection was part of research study; trial overlapped with COVID-19 pandemic; patient navigators were unblinded; trial was not powered to test differences in follow-up; samples were tested using the non-FDA approved Aptima HPV test; FDA approved self-collection in clinical settings following completion of trial.'}}, 'adverseEventsModule': {'timeFrame': 'Within 6 months post randomization', 'description': 'Study participants were asked to report any adverse events during the use of the HPV self-collection kit. Reported AEs were assessed within 6 months of randomization.\\*\\*\n\n\\*\\*AEs are for when participants are "on treatment" so would have been within 6 months post randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.', 'otherNumAtRisk': 828, 'deathsNumAtRisk': 828, 'otherNumAffected': 0, 'seriousNumAtRisk': 828, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.', 'otherNumAtRisk': 828, 'deathsNumAtRisk': 828, 'otherNumAffected': 0, 'seriousNumAtRisk': 828, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.\n\nPatient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.", 'otherNumAtRisk': 818, 'deathsNumAtRisk': 818, 'otherNumAffected': 1, 'seriousNumAtRisk': 818, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 828, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 828, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 818, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Screening Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '828', 'groupId': 'OG000'}, {'value': '828', 'groupId': 'OG001'}, {'value': '818', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.'}, {'id': 'OG001', 'title': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.'}, {'id': 'OG002', 'title': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.\n\nPatient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample."}], 'classes': [{'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Relative Participation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '1.99', 'ciUpperLimit': '2.80', 'pValueComment': '95% CIs were calculated.', 'groupDescription': 'Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 6 months of randomization', 'description': 'cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Screening Tests Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.'}, {'id': 'OG001', 'title': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.'}, {'id': 'OG002', 'title': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.\n\nPatient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample."}], 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}, {'title': 'Negative', 'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}, {'title': 'Inadequate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 6 months of randomization', 'description': 'Results of HPV test using self-collected samples (positive, negative, or inadequate)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participated in cervical cancer screening'}, {'type': 'SECONDARY', 'title': 'Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.'}, {'id': 'OG001', 'title': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.'}, {'id': 'OG002', 'title': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.\n\nPatient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample."}], 'classes': [{'categories': [{'title': 'Attended follow up', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}, {'title': 'Did not attend follow up', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.', 'description': 'Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an abnormal screening result, including those received from a clinic-based screening or mailed HPV self-sampling kit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.'}, {'id': 'FG001', 'title': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.'}, {'id': 'FG002', 'title': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.\n\nPatient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '828'}, {'groupId': 'FG001', 'numSubjects': '828'}, {'groupId': 'FG002', 'numSubjects': '818'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '821'}, {'groupId': 'FG001', 'numSubjects': '737'}, {'groupId': 'FG002', 'numSubjects': '715'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '103'}]}], 'dropWithdraws': [{'type': 'Terminated phone call early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Terminated phone call early or requested to not receive a kit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '103'}]}]}], 'recruitmentDetails': 'Trial enrollment began February 20,2020, then paused March 27, 2020, due to clinic closures and restrictions on human participant research following the declaration of the COVID-19 pandemic. Trial enrollment resumed August 3,2020 and continued through August 31, 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '828', 'groupId': 'BG000'}, {'value': '828', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}, {'value': '2474', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.'}, {'id': 'BG001', 'title': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.'}, {'id': 'BG002', 'title': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.\n\nTelephone Recall: Participants receive a scripted telephone recall from a trained patient navigator.\n\nMailed HPV Self-Sampling Kit: Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.\n\nPatient Navigation: Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '57'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '58'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '57'}, {'value': '49', 'groupId': 'BG003', 'lowerLimit': '39', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '828', 'groupId': 'BG000'}, {'value': '828', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}, {'value': '2474', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '578', 'groupId': 'BG000'}, {'value': '548', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}, {'value': '1655', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic Black or African American', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic Other or Unknown', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '828', 'groupId': 'BG000'}, {'value': '828', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}, {'value': '2474', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of health care coverage', 'classes': [{'categories': [{'title': 'Private insurance', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}, {'value': '737', 'groupId': 'BG003'}]}, {'title': 'Publicly funded financial assistance plan', 'measurements': [{'value': '476', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}, {'value': '1388', 'groupId': 'BG003'}]}, {'title': 'Medicaid', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}, {'title': 'Medicare', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-25', 'size': 946765, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-18T10:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2019-03-29', 'resultsFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Screening Participation', 'timeFrame': 'within 6 months of randomization', 'description': 'cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.'}], 'secondaryOutcomes': [{'measure': 'Screening Tests Results', 'timeFrame': 'within 6 months of randomization', 'description': 'Results of HPV test using self-collected samples (positive, negative, or inadequate)'}, {'measure': 'Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result', 'timeFrame': 'Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.', 'description': 'Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening', 'Human Papillomavirus Infection', 'Self-Testing'], 'conditions': ['Cervical Cancer', 'Human Papillomavirus Infection']}, 'referencesModule': {'references': [{'pmid': '33087164', 'type': 'BACKGROUND', 'citation': 'Montealegre JR, Anderson ML, Hilsenbeck SG, Chiao EY, Cantor SB, Parker SL, Daheri M, Bulsara S, Escobar B, Deshmukh AA, Jibaja-Weiss ML, Zare M, Scheurer ME. Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial. Trials. 2020 Oct 21;21(1):872. doi: 10.1186/s13063-020-04790-5.'}, {'pmid': '37316815', 'type': 'BACKGROUND', 'citation': 'Amboree TL, Parker SL, Bulsara S, Anderson ML, Schmeler KM, Chiao EY, Montealegre JR. Cervical cancer screening among English- and Spanish-speaking Hispanic women in an urban safety net health system, 2015-2020. BMC Womens Health. 2023 Jun 15;23(1):309. doi: 10.1186/s12905-023-02448-3.'}, {'pmid': '37232493', 'type': 'RESULT', 'citation': 'Parker S, Deshmukh AA, Chen B, Lairson DR, Daheri M, Vernon SW, Montealegre JR. Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Elife. 2023 May 26;12:e84664. doi: 10.7554/eLife.84664.'}, {'pmid': '37935320', 'type': 'RESULT', 'citation': 'Parker SL, Amboree TL, Bulsara S, Daheri M, Anderson ML, Hilsenbeck SG, Jibaja-Weiss ML, Zare M, Schmeler KM, Deshmukh AA, Chiao EY, Scheurer ME, Montealegre JR. Self-Sampling for Human Papillomavirus Testing: Acceptability in a U.S. Safety Net Health System. Am J Prev Med. 2024 Mar;66(3):540-547. doi: 10.1016/j.amepre.2023.10.020. Epub 2023 Nov 5.'}, {'pmid': '40478588', 'type': 'DERIVED', 'citation': 'Montealegre JR, Hilsenbeck SG, Bulsara S, Parker SL, Amboree TL, Anderson ML, Daheri M, Jibaja-Weiss ML, Schmeler KM, Deshmukh AA, Chiao EY, Scheurer ME. Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1119-1127. doi: 10.1001/jamainternmed.2025.2971.'}]}, 'descriptionModule': {'briefSummary': 'Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. This study evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.', 'detailedDescription': 'Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. This study is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no history of hysterectomy or cervical cancer\n* no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years\n* patient of Harris Health System in Harris County (Houston), Texas\n* have at least 2 visits to ambulatory care within Harris Health System in the past 5 years\n* be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months\n\nExclusion Criteria:\n\n* no valid telephone contact information\n* unable to communicate in English or Spanish\\*\n* currently pregnant\n* history of cervical dysplasia in the past 3.5 years'}, 'identificationModule': {'nctId': 'NCT03898167', 'acronym': 'PRESTIS', 'briefTitle': 'Prospective Evaluation of Self-Testing to Increase Screening', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System', 'orgStudyIdInfo': {'id': 'H-44944'}, 'secondaryIdInfos': [{'id': 'R01MD013715', 'link': 'https://reporter.nih.gov/quickSearch/R01MD013715', 'type': 'NIH'}, {'id': 'R01MD013715-04S2', 'link': 'https://reporter.nih.gov/quickSearch/R01MD013715-04S2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Telephone Recall', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.', 'interventionNames': ['Behavioral: Telephone Recall']}, {'type': 'EXPERIMENTAL', 'label': 'Mailed HPV Self-Sampling Kit', 'description': 'Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope.', 'interventionNames': ['Behavioral: Telephone Recall', 'Behavioral: Mailed HPV Self-Sampling Kit']}, {'type': 'EXPERIMENTAL', 'label': 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'description': "Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.", 'interventionNames': ['Behavioral: Telephone Recall', 'Behavioral: Mailed HPV Self-Sampling Kit', 'Behavioral: Patient Navigation']}], 'interventions': [{'name': 'Telephone Recall', 'type': 'BEHAVIORAL', 'description': 'Participants receive a scripted telephone recall from a trained patient navigator.', 'armGroupLabels': ['Mailed HPV Self-Sampling Kit', 'Mailed HPV Self-Sampling Kit + Patient Navigation', 'Telephone Recall']}, {'name': 'Mailed HPV Self-Sampling Kit', 'type': 'BEHAVIORAL', 'description': 'Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.', 'armGroupLabels': ['Mailed HPV Self-Sampling Kit', 'Mailed HPV Self-Sampling Kit + Patient Navigation']}, {'name': 'Patient Navigation', 'type': 'BEHAVIORAL', 'description': 'Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.', 'armGroupLabels': ['Mailed HPV Self-Sampling Kit + Patient Navigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Harris Health System', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jane R Montealegre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'De-identified data are available to study team members now and will be made available until primary, secondary and exploratory analyses are complete.', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared on primary and secondary outcomes. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant).', 'accessCriteria': 'Listed on IRB-approved protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jane Montealegre', 'investigatorAffiliation': 'M.D. Anderson Cancer Center'}}}}